BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 ROLLER PUMP

    MDR report key: 2904674 · Received January 4, 2013

    Report

    Report Number
    1718850-2012-01112
    Event Type
    Other
    Date Received
    January 4, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 7, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN THE (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT A REDUCTION OF THE BLOOD LEVEL IN THE RESERVOIR BELOW THE MINIMUM VOLUME CAUSED THE PUMP TO STOP DURING A PROCEDURE. THE PUMP DID NOT RESTART WHEN THE LEVEL WAS INCREASED ABOVE THE MINIMUM VOLUME. HAND-CRANKING WAS USED TO MAINTAIN BLOOD FLOW UNTIL FUNCTION WAS REGAINED BY POWER CYCLING THE PUMP. THE LEVEL DETECTOR WAS NOT RESET. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A REDUCTION OF THE BLOOD LEVEL IN THE RESERVOIR BELOW THE MINIMUM VOLUME CAUSED THE PUMP TO STOP DURING A PROCEDURE. THE PUMP DID NOT RESTART WHEN THE LEVEL WAS INCREASED ABOVE THE MINIMUM VOLUME. HAND-CRANKING WAS USED TO MAINTAIN BLOOD FLOW UNTIL FUNCTION WAS REGAINED BY POWER CYCLING THE PUMP. THE LEVEL DETECTOR WAS NOT RESET. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5265 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 10-80-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1